WithdrawnNot Applicable

Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)

Stopped: Administrative decision

0Started 2022-12-31

Plain-language summary

Evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders.

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. Men and women ≥ 20 and ≤ 80 years of age.
✓. Patients who are able and willing to give consent and physically and practically able to attend study visits, as determined by both study psychiatrist and the surgeon.
✓. DSM-V diagnosis of major depressive disorder (MDD), or bipolar disorder with predominant depressive symptoms.
✓. At least 5-year illness history of the primary disorder and at least 6 months since the onset of the first episode of major depression.
✓. A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed (patients with bipolar disorder may be rapid cycling, but must have at least 2 weeks of major depression at the time the HAMD is conducted).
✓. Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by a psychiatrist associated with the study. Including specifically:
✓. Failed to respond or tolerate adequate trials of three or more medications accepted as first line therapies in the treatment of depression.
✓. Failed to respond or tolerate augmentation with or combination of at least 2 medications known to be first line treatments for depression.

Exclusion criteria

✕. Patients with unstable cardiac status \[e.g., unstable angina pectoris on medication, patients with documented myocardial infarction within six months, congestive heart failure requiring medication (other than diuretics), patients on anti-arrhythmic drugs, severe hypertension (defined as systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 100 mm Hg while on medication)\].
✕. Patients with standard contraindications for MRI imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
✕. Severely impaired renal function (estimated glomerular filtration rate \< 30 ml/min/1.73 m2) or receiving dialysis.
✕. Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR).
✕. Cerebrovascular disease (e.g., CVA within 6 months) or history of intracranial hemorrhage.
✕. Untreated, uncontrolled sleep apnea.
✕. Receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure.
✕. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment.

What they're measuring

Serious Adverse Events

Timeframe: Time of Exablate transcranial procedure

Change in Quality of Life per the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)

Timeframe: 12 months

Trial details

NCT IDNCT05089786

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-31

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